Trial · NCT03102645
Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
NCT03102645, Phase 1, Completed, Jonatan Kornholt; results first posted 2021-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter? Trials, record NCT03102645. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03102645
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
- NCT number
- NCT03102645
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 16 participants, actual
- Lead sponsor
- Jonatan Kornholt
- Conditions
- Urinary Incontinence, Stress, Fecal Incontinence
- Interventions
- Placebo Oral Tablet, Imipramine Hydrochloride 25 MG
- First posted
- 2017-04-06
- Last updated
- 2021-02-12
- Results first posted
- 2021-02-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urethral Opening Pressure (UOP) | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. | Mean change in UOP (baseline and 1 hour after drug administration). Measured with Urethral Pressure Reflectometry (UPR). |
| Secondary | Anal Opening Pressure (AOP) | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. | Mean change in AOP (baseline and 1 hour after drug administration). Measured with Anal Acoustic Reflectometry (AAR). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Urethral Opening Pressure (UOP) | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. | cmH2O | MEAN | |
| SECONDARY | Anal Opening Pressure (AOP) | Immediately before drug/placebo administration (baseline) and 1 hour after drug/placebo administration on both study days. | cmH2O | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urethral Opening Pressure (UOP) | Imipramine | 2.90411 | Standard Deviation 13.24729 | cmH2O | |
| Urethral Opening Pressure (UOP) | Placebo | -3.623431 | Standard Deviation 8.279883 | cmH2O | |
| Anal Opening Pressure (AOP) | Imipramine | 12.11873 | Standard Deviation 15.79818 | cmH2O | |
| Anal Opening Pressure (AOP) | Placebo | -2.989054 | Standard Deviation 16.40355 | cmH2O |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Imipramine First | 8 | |
| Overall Study | STARTED | Placebo First | 8 | |
| Overall Study | COMPLETED | Imipramine First | 8 | |
| Overall Study | COMPLETED | Placebo First | 8 | |
| Overall Study | NOT COMPLETED | Imipramine First | 0 | |
| Overall Study | NOT COMPLETED | Placebo First | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Stomach cramps | Gastrointestinal disorders | Imipramine | 0 | 16 | 0 |
| other | Stomach cramps | Gastrointestinal disorders | Placebo | 1 | 16 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Imipramine | 3 | 16 | 3 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 0 | 16 | 0 |
| other | Tired | General disorders | Imipramine | 5 | 16 | 5 |
| other | Tired | General disorders | Placebo | 0 | 16 | 0 |
| other | Dizzy | Nervous system disorders | Imipramine | 3 | 16 | 3 |
| other | Dizzy | Nervous system disorders | Placebo | 0 | 16 | 0 |
| other | Migraine | Nervous system disorders | Imipramine | 1 | 16 | 1 |
| other | Migraine | Nervous system disorders | Placebo | 0 | 16 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imipramine | 0 | 16 |
| Total, all-cause mortality | Placebo | 0 | 16 |
| Total, other adverse events | Imipramine | 7 | 16 |
| Total, other adverse events | Placebo | 1 | 16 |
| Total, serious adverse events | Imipramine | 0 | 16 |
| Total, serious adverse events | Placebo | 0 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39167201 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Imipramine vs Placebo: deaths from any cause | Trial comparisons |
| Imipramine vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03102645
GET https://conductscience.org/api/trials/v1/NCT03102645/registered